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A Blood Test to Detect Early Signs of Pre-eclampsia in Pregnancy Using DNA Fragments

Plasma cffDNA Profiling for Early Pregnancy PreEclampsia Screening

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/06/088167
Enrollment
2200
Registered
2025-06-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O141- Severe pre-eclampsia

Interventions

Intervention1: Nil: Nil

Sponsors

ALL INDIA INSTITUTE OF MEDICAL SCIENCES
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pregnant women between 11 14 weeks of gestation 2. Singleton pregnancies with confirmed dating 3. Willing and able to provide informed consent 4. Planning to continue antenatal care and delivery at the study site

Exclusion criteria

Exclusion criteria: 1. Twin Pregnancies 2. Other high risk pregnancies like Diabetes Mellitus, Rh immunized pregnancies, SLE etc.

Design outcomes

Primary

MeasureTime frame
Assessment of PE-specific methylation signature in plasma-based cffDNA (circulating cell-free fetal DNA) fractionsTimepoint: comparing the maternal and fetal cell free DNA using different methods. the sample will be tested in between 11-14 weeks

Secondary

MeasureTime frame
1. Compare predictive performance against standard multiparametric algorithms 2. Determine the feasibility of clinical implementation as a non-invasive screening tool.Timepoint: 1. Performance comparison will be done after pregnancy outcomes are known (retrospectively comparing first-trimester data with final diagnoses) between 11-14 weeks 2. Evaluation will occur throughout the study duration, focusing on sample processing, test performance, & ease of implementation.

Countries

India

Contacts

Public ContactDr K Aparna Sharma

All India Institute of Medical Sciences, Delhi

kaparnasharma@gmail.com9711824415

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026